Review of Probiotic Trial Research Finds Only Bifantis Able to
Claim Efficacy versus Placebo for IBS Symptoms

Of 13 studies analyzed, only Bifantis used appropriate study design
to demonstrate efficacy compared with placebo

PHILADELPHIA, October 15, 2007 /PRNewswire/ -- A new analysis of
randomized controlled trials evaluating probiotics in the treatment
of irritable bowel syndrome (IBS) has found that Bifantis(R),
Bifidobacterium infantis 35624, the sole ingredient in Align(R)
(manufactured by Procter & Gamble), is the only probiotic
currently able to demonstrate significant improvement in IBS
symptoms based upon a properly designed research study. Researchers
at the University of Michigan conducted the review to evaluate the
safety, efficacy and tolerability of probiotics for IBS in
randomized controlled trials and found that, with the exception of
the Bifidobacterium infantis 35624 studies, most were not designed
in a way that made the data possible to validate. The review data
were presented this week at the annual of Gastroenterology (ACG)
conference taking place in Philadelphia, PA.

"There is growing interest in medical and patient communities
about the use of probiotics in IBS and lots of data has been
published about this topic, but it's helpful to know the quality of
that data before making a treatment decision," said Darren Brenner,
MD, lead investigator on this project. "Our analysis showed that
only this particular strain of probiotic, Bifidobacterium infantis
35624, has valid data for successfully treating IBS symptoms. At
this point, we just don't have enough valid data to determine if
other probiotics are effective for IBS."

The Study

The goal of this systematic review of randomized controlled
trials was to evaluate the efficacy, safety and tolerability of
probiotics in the treatment of IBS. Criteria for the study included
randomized controlled trials testing adults with IBS symptoms using
single or combination probiotics versus placebo for IBS symptoms
and frequency of adverse events.

Of the 13 trials that met selection criteria, 11 demonstrated
sub-optimal study design with inadequate blinding, inadequate trial
length, inadequate sample size and lack of proper analysis. Only
three studies provided quantifiable data about tolerability and
adverse events, and the only probiotic to demonstrate significant
improvement in IBS symptoms in appropriately designed studies was
Bifidobacterium infantis 35624.

Bifidobacterium infantis 35624 showed significant improvement in
the composite score of abdominal pain/discomfort,
bloating/distention and bowel movement difficulty compared with
placebo. A subsequent study showed that Bifidobacterium infantis
35624 demonstrated superior efficacy to the placebo for the primary
outcome measure of abdominal pain/discomfort as well as for
secondary measures including bloating/distention, incomplete
evacuation, straining and passage of gas.

"From our discovery of the bacterium to the description of its
genome and biological properties and, finally, to the clinical
studies that have made this available to consumers in Align, our
primary goal has been to provide accurate information on the
benefits of Bifantis," said Eamonn Quigley, MD FACG and professor
of Medicine and Human Physiology and Head of the Medical School,
National University of Ireland (NUI).

About Alimentary Health

Alimentary Health is a development stage specialty biotechnology
company located in Ireland. The company is focused on the
discovery, development and commercialization of proprietary
probiotic and pharmabiotic treatments for gastrointestinal
disorders and other inflammatory conditions. Alimentary Health is
the foundation industry partner of the Alimentary Pharmabiotic
Center based at University College Cork, Ireland. Please visit
www.alimentaryhealth.ie for
more information.

About APC

The Alimentary Pharmabiotic Centre (APC) is a Science Foundation
Ireland (SFI) funded research centre headquartered in University
College Cork (UCC), with scientists and clinicians also based in
Teagasc Moorepark, Cork University Hospital and Alimentary Health
Ltd. The APC is investigating mechanisms by which intestinal
bacteria influence health and disease and is developing new
therapies for lifelong debilitating gastrointestinal diseases such
as gastroenteritis, ulcerative colitis and Crohn's disease. For
information please visit http://apc.ucc.ie/.

About Align

Align is a daily probiotic supplement that helps build and
maintain a strong and healthy digestive system.* Align works by
providing a natural defense against episodic digestive upsets such
as constipation, diarrhea, abdominal discomfort, urgency, gas and
bloating. Align is the only probiotic supplement containing
Bifantis (Bifidobacterium infantis 35624). Please visit AlignGI.com
for more information.